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Completed Phase 2 Interventional Results available

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT05686408

Public ClinicalTrials.gov record NCT05686408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).

Study identification

NCT ID
NCT05686408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2, 2023 (Actual)
Primary completion
Sep 29, 2023 (Actual)
Completion
Sep 29, 2023 (Actual)
Last update posted
Feb 17, 2025

2023

United States locations

U.S. sites
27
U.S. states
13
U.S. cities
27
Facility City State ZIP Site status
Preferred Research Partners Little Rock Arkansas 72211 —
Cenexel CIT - Bellflower Bellflower California 90706 —
Behavioral Research Specialists Glendale California 91206 —
Synergy Research Lemon Grove California 91945 —
Excell Research Oceanside California 92056 —
NCR Research Institute Orange California 92868 —
Cenexel CIT - Riverside Riverside California 92506 —
Artemis Institute for Clinical Research San Diego California 92103 —
Cenexel CNR - Sherman Oaks Sherman Oaks California 91403 —
Viking Clinical Research Temecula California 92951 —
Mountain View Clinical Research Denver Colorado 80209 —
CT Clinical Research Associates Cromwell Connecticut 06416 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
Clinical Neuroscience Solutions - Jacksonville Jacksonville Florida 32256 —
West Broward Outpatient Clinic Lauderhill Florida 33319 —
Segal Trials - North Miami Miami Lakes Florida 33016 —
Clinical Neuroscience Solutions - Orlando Orlando Florida 32801 —
Cenexel ACMR - Atlanta Atlanta Georgia 30331 —
Cenexel Research - Decatur Decatur Georgia 30030 —
Northwest Clinical Trials Boise Idaho 83704 —
Chicago Research Center Chicago Illinois 60634 —
Cenexel HRI - Berlin Berlin New Jersey 08009 —
Summit Research Network Portland Oregon 97210 —
Clinical Neuroscience Solutions - Memphis Memphis Tennessee 38119 —
Donald J. Garcia, Jr. Austin Texas 78737 —
Futuresearch Trials of Dallas Dallas Texas 75231 —
Core Clinical Research Everett Washington 98201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05686408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 17, 2025 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05686408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →